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Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus


Inclusion Criteria:



- ≥18 years of age

- Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation
or inversion event involving the ALK gene locus

- Clinical response to treatment with crizotinib as defined by either:

Radiographic partial or complete response defined by RECIST or WHO

OR:

Radiographic stable disease for at least 8 weeks

- Radiographic progression of disease amenable to biopsy while on treatment with
crizotinib as defined by RECIST or WHO

- Signed informed consent

Exclusion Criteria:

- Deemed by their treating physician to be medically unfit for biopsy

- Women who are pregnant or breast-feeding

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Gregory Riely, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-014

NCT ID:

NCT01300429

Start Date:

February 2011

Completion Date:

February 2014

Related Keywords:

  • Lung Cancer
  • core biopsy
  • Resistance to Crizotinib
  • Non-small Cell Lung Cancer
  • 11-014
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021